| Methods |
Design: three group parallel trial
Purpose: study the effect of placebo treatment and patient‐practioner relationship |
| Participants |
Patients: outpatients with irritable bowel syndrome
Baseline comparability: yes |
| Interventions |
Placebo: sessions of needling with a sham needle that does not penetrate the skin and limited patient‐provider interaction ('placebo acupuncture alone')
Untreated: no session
Experimental: sessions of needling with a sham needle that does not penetrate the skin and extensive patient‐provider interaction (placebo acupuncture augmented by warmth, attention and confidence')
(Co‐intervention: NS) |
| Outcomes |
Global improvement scale scores (1 to 7 point )
Proportion of patients with adequate relief
Symptom severity scale
Quality of life scale |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Low risk |
'sequentially numbered opaque sealed envelopes' |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/acupuncture) |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop‐out < 15% |
| Free of selective reporting? |
Unclear risk |
No primary outcomes mentioned in the protocol. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
Low risk |
N = 175 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
Low risk |
All three categories fulfilled |
